Index of drugs

Supporting induction of labor at a time when it is necessary for obstetric or internal reasons.

3 g of gel contains 500 μg of dinoprostone.

Dinoprostone is prostaglandin E2 (PGE2), belongs to the group of natural unsaturated fatty acids. Administered to the cervix, it accelerates its maturation to support the induction of labor. The exact mechanism of action has not yet been fully elucidated, however, it has been experimentally shown that after the administration of dinoprostone, the volume of circulating blood in the neck increases, as in the early stages of spontaneous delivery. After administration to the cervix 500 μg of dinoprostone (as a gel) the maximum plasma concentration was observed after 30-40 min. Then this level quickly returns to normal regardless of uterine contractions.

Hypersensitivity to prostaglandins or to any of the excipients. Use in patients with contraindications for use in uterine contracture preparations, or in whom prolonged uterine contractions are contraindicated, e.g. in the following cases: multiple pregnancy; high-order multi-nationality (six or more full term pregnancies); delayed insertion of the head; previous uterine operations such as cesarean section or hysterectomy; delivery incidence (pelvicanoid); sudden obstetric conditions, in which the risk-benefit ratio for the fetus or for the mother speaks for a surgical operation; fetal non-head position; clinical suspicion of early fetal distress based on his heart function; infection of the lower genital tract; undiagnosed discharge and / or abnormal bleeding during pregnancy; difficult and / or traumatic birth in an interview; part leading over the pelvis; active heart, lung, kidney or liver disease; rupture of the membranes of the fetus; the leading bearing.

The preparation should be used only in hospitals and clinics with specialist gynecological wards and only when 24-hour medical care is provided. Before and during its administration, careful monitoring of uterine contractions, fetal condition and cervical features (opening, softening and dilation) is necessary to detect any adverse reactions, eg excessive tension, persistent uterine contractions or fetal distress. In the case of uterine hypertension found in the past or its excessive contractility, continuous monitoring of spasms and the condition of the mother and the fetus should be recommended. Caution is required in patients with circulatory, hepatic or renal disorders, active asthma or asthma, glaucoma (or increased intraocular pressure), epilepsy, hypertension or a history of ruptured membranes. In the case of sustained strong contractions, the risk of uterine rupture should always be taken into account. The pelvic-aspect ratio should be carefully assessed before use. Treatment of patients with excessive tension of the uterine wall or its excessive contractility, or whose fetal heart activity is of concern should be aimed at preserving the good condition of the general fetus and mother. In case of excessive activity or abnormal uterine pain, the possibility of uterine rupture should be taken into account. The consequence of a rupture of the uterus may be the circulation of a pregnant woman embolic tissue material of fetal origin (including amniotic fluid). Due to the presence of fetal antigens in this tissue material, anaphylactoid reaction may occur in women. "anaphylactoid pregnancy syndrome". The use of exogenous prostaglandins may increase the response to oxytocin. In newborns who were treated for a long time with prostaglandin E1 bone hyperplasia was observed; this type of effect on bones has not been demonstrated during short-term use. The gel should not be applied above the mouth of the cervix, because excessive uterine stimulation has been observed with extrinsic administration.Patients with severe kidney or liver disease associated with metabolic disorders should be monitored more closely.

The preparation can be used only during pregnancy to help induce labor.

In the mother: cardiac arrest, hypersensitivity reactions (eg anaphylactic reaction, anaphylactic shock, anaphylactoid reaction), asthma, bronchospasm, cough, shortness of breath, tightness in the chest, tuberculous rales above the pulmonary fields, diarrhea, nausea, vomiting, rash , back pain, hypertension, abnormal uterine contractions (occurring with increased frequency, with increased tension or prolonged in time) with or without alteration of fetal heart rate, uterine rupture, placental abruption, pulmonary embolism / embolism with amniotic fluid, sudden widening of the cervix uterus, warmth, pain, vaginal irritation, fever, increase in the number of white blood cells. In the fetus / newborn: fetal distress condition / fetal heart rate abnormalities during or following treatment with the preparation, post-partum assessment of the baby at less than 7 points on the Apgar scale, fetal acidosis. Pregnancy, puerperium and perinatal period: delivery of a dead fetus, preterm delivery. There is a risk of local infections as a result of the hydrophobic administration of the gel.

Application to the cervix. In order for the product to be properly administered, the patient should lie on her back and have her vaginal speculum inserted to reveal the cervix. The entire contents of the syringe (3 g) should be injected gently and sterilely into the cervical canal using a sterile plastic catheter attached to the packaging. Then, gently remove the plastic catheter from the cervical canal. The gel should not be applied above the inner neck. After applying the gel, the patient should remain supine for at least 15 minutes to minimize the flow of the gel. The contents of the syringe can be used only in one patient. Do not try to administer a small amount of gel remaining in a plastic catheter.